跳至主要内容
临床试验/NCT04831411
NCT04831411已完成不适用

Comparison of Early Whole Body Vibration and Progressive Resistance Training to Enhance Recovery After Fast-Track Total Knee Arthroplasty: A Randomized Comparative Study.

Pamukkale University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Quadriceps muscle strength

研究概览

简要总结

Patients who have undergone total knee arthroplasty (TKA) with Fast-Track recovery protocol at the Department of Orthopedics and Traumatology at the Local University Hospital and meet the inclusion and exclusion criteria will constitute the study sample. The patients will be divided into 2 groups using the computerized randomization method in the post-operative 4th week; Whole Body Vibration Group and Progressive Resistance Exercise Group. The first evaluation of the participants will be made at the end of the post-operative 4th week. Final evaluations will be made at the end of the post-operative 10th week, following the 6-week training.

详细描述

Patients who have undergone total knee arthroplasty (TKA) with Fast-Track recovery protocol at the Department of Orthopedics and Traumatology at the Local University Hospital and meet the inclusion and exclusion criteria will constitute the study sample. The patients will be divided into 2 groups using the computerized randomization method in the post-operative 4th week; Whole Body Vibration Group and Progressive Resistance Exercise Group. The first evaluation of the participants will be made at the end of the post-operative 4th week. After 2 days and 6 weeks of training a week, final evaluations will be made at the end of the 10th postoperative week. Evaluations will include measures of impairment in body functions and structures, activity limitation measures, balance assessment, and quality of life assessments. Evaluations will be made by a blind researcher. The study will be started with a total of 28 patients, including 14 participants in both groups. The sample size was determined by performing a power analysis. The purpose of the study will be explained to the patients by the researcher and the patients who agree to participate in the planned study will be included in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing unilateral TKA surgery due to knee OA,
  • Being between the ages of 50-75,
  • To be able to understand the verbal and written information given.

排除标准

  • To undergo revision TKA surgery.
  • Participating in any exercise or strengthening training within the last 3 months.
  • Having undergone major surgery on the extremity to be operated on.
  • Having a comorbid disease such as rheumatoid arthritis, cancer.
  • Having a neurological disease that causes functional insufficiency.
  • Having a diagnosed psychiatric disorder.
  • Having received anaesthesia for any reason in the last 1 month.
  • Regularly using hypnotics or anxiolytics.
  • Having dementia.
  • Having a hearing or vision impairment that cannot be corrected with a hearing aid or glasses.
  • Being morbidly obese (Body mass index> 40 kg/m2).
  • Having implanted pacemakers or defibrillators.
  • Having dermatological problems affecting the thigh.
  • Having a score above 3 in the American Society of Anesthesiologists classification score.

结局指标

主要结局

Quadriceps muscle strength

时间窗: 6 weeks

A handheld dynamometer (Commander Muscle Tester, JTech, USA) will be used for quadriceps muscle strength measurement. Patients will be seated on the treatment table with their hips and knees in 90 ° flexion with their feet hanging down. In this position, the hands will be on crossed shoulders and the use of bodyweight will be prevented. During the measurements, verbal guidance will be given to the patients in order to achieve maximum effort. Measurements will be made from the distal anterior face of the tibia with 3 consecutive maximum isometric contractions. The average of the measurement values will be recorded as a score.

Balance

时间窗: 6 weeks

Kinesthetic Ability Trainer® (KAT Model TS 650) will be used to evaluate balance. Patients will use the lines on the platform to place their feet in the same place for each measurement. Patients will be informed that the cursor on the system interface indicating the location of the pressure centre should be moved as little as possible and kept close to the centre. The rates of pressure centre change will be recorded as a result of the balance score obtained after 30 seconds of measurements on bipedal feet. Measurements will be applied in 3 repetitions and their average will be recorded and recorded in the study.

次要结局

  • Sit-to-stand test(6 weeks)
  • Pain assesment(6 weeks)
  • Western Ontario and McMaster Universities Osteoarthritis Index score(6 weeks)
  • Timed up and go test(6 weeks)
  • Quality of life measure(6 weeks)
  • 40 m fast-paced walk test(6 weeks)
  • Stair climbing test(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gökhan Bayrak

Director

Pamukkale University

研究点 (1)

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